(100 days)
The Symphony Meter Remote is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood, and as a wireless (RF) remote control to deliver insulin from the Symphony Pump. The Symphony Meter Remote is intended for use for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home and by healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. The Symphony Meter Remote is specifically indicated for use on the finger, forearm or palm. It should not be used for the diagnosis of diabetes or testing of newborns.
The Symphony Meter Remote is designed to function both as an in vitro diagnostic device for self-monitoring blood glucose (measure blood glucose concentrations) and as a remote controller of a Symphony Pump for insulin delivery through an infusion set placed subcutaneously.
The Symphony Meter Remote is a reusable handheld-battery operated device supplied clean and non-sterile to primarily function as a stand-alone blood glucose meter. With user activation of RF communication between a specific Symphony Meter Remote and specific Symphony Pump, the Symphony Meter Remote also becomes a remote controller of certain features of the Symphony Pump. When paired through radio frequency (RF) communication the Symphony Meter Remote can be used to control bolus insulin delivery, review the status of the Symphony Pump and view and confirm selected pump alerts and warnings.
The Symphony Meter Remote incorporates other design features that utilize glucose test data, insulin delivery data, and information important to overall diabetes management, as well as provide interface capability with a personal computer (PC) via data management software.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Symphony Meter Remote, based on the requested information.
Note: The provided text is a 510(k) summary for a remote control device with integrated blood glucose meter. It focuses heavily on regulatory equivalence and does not contain detailed technical performance studies or acceptance criteria for the blood glucose measurement component itself. The document states: "Performance evaluations, both bench and clinical, of the Symphony Meter Remote were completed and did not raise any new issues of safety and effectiveness." This implies that the specific performance criteria and studies for the glucose meter are assumed to be covered by the predicate device (Symphony Glucose Management System K080639), and this submission is primarily for the remote control functionality. Therefore, I will synthesize what can be inferred or directly stated from the text.
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly state numerical acceptance criteria or performance metrics for the Symphony Meter Remote beyond its function as a remote control. It relies on the substantial equivalence to a predicate device (Symphony Glucose Management System, K080639).
However, as the device incorporates a glucose test system, general performance expectations for blood glucose meters typically involve accuracy metrics (e.g., ISO 15197 standards). Since the document claims: "Performance evaluations, both bench and clinical, of the Symphony Meter Remote were completed and did not raise any new issues of safety and effectiveness," this suggests the blood glucose monitoring function met relevant established performance standards.
Given the lack of explicit data in this specific document, I will present the information based on the typical requirements for such devices, acknowledging that the specific numerical values are not present here.
| Acceptance Criteria (Inferred/Typical for BGM) | Reported Device Performance (Inferred from "no new issues") |
|---|---|
| Accuracy (Blood Glucose Measurement) | (Implied to meet established BGM accuracy standards, likely ISO 15197, as no new safety/effectiveness issues were raised compared to predicate.) |
| - Within ±15% of lab reference for values >75 mg/dL | (No specific numerical data provided in this document) |
| - Within ±15 mg/dL of lab reference for values ≤75 mg/dL | (No specific numerical data provided in this document) |
| Precision (Repeatability) | (Implied to meet established BGM precision standards) |
| - Low coefficient of variation (CV) | (No specific numerical data provided in this document) |
| User Performance/Usability | (Implied to be safe and effective for intended users, given predicate equivalence) |
| RF Communication Reliability | (Implied to be reliable for controlling insulin pump, as no new issues were raised) |
| Safety | (Implied to be safe for intended use) |
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) summary for K082570 provides no specific details regarding the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective) for the "Performance evaluations, both bench and clinical." The statement indicates these evaluations were completed but does not provide their specifics. Since it refers to "no new issues" compared to the predicate (K080639), it implies reliance on the studies performed for the predicate device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the 510(k) summary. For blood glucose meters, ground truth is typically established by laboratory reference methods (e.g., YSI analyzer) performed by trained lab personnel, not necessarily "experts" in the clinical review sense.
4. Adjudication Method for the Test Set
This information is not provided in the 510(k) summary. Given the nature of blood glucose measurement, "adjudication" in the sense of reconciling divergent expert opinions is not typically applicable. Ground truth for blood glucose is established by validated laboratory instruments.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or mentioned. MRMC studies are typically used for diagnostic imaging devices where human interpretation varies. This device is a blood glucose meter and a remote control, which does not involve "reading" cases in that context.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
The "Performance evaluations, both bench and clinical" would encompass standalone performance of the blood glucose meter component. The phrase "did not raise any new issues of safety and effectiveness" suggests that the standalone performance as a blood glucose meter was sufficient and comparable to the predicate. However, detailed results of this standalone testing are not provided in this summary.
7. The Type of Ground Truth Used
For the blood glucose measurement function, the ground truth would typically be established using laboratory reference methods (e.g., a YSI Glucose Analyzer). The document does not explicitly state this, but it is the standard for blood glucose meter validation. For the remote control functionality, the ground truth would involve successful and accurate control commands being transmitted and executed by the insulin pump, which would be assessed through functional testing.
8. The Sample Size for the Training Set
The 510(k) summary does not provide any information regarding a training set sample size. This type of detail is more common for devices employing machine learning algorithms, which is not suggested to be the primary mechanism for the blood glucose measurement in this device generation. For a blood glucose meter, "training" in the ML sense is not typically applicable in the same way; calibration and robustness testing are usually performed.
9. How the Ground Truth for the Training Set Was Established
As no training set is described or implied for an AI/ML context, this information is not applicable in the context of this 510(k) summary. If a "training set" refers to samples used for device calibration, the ground truth would be established using laboratory reference methods, similar to the test set.
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).